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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, spinal pedicle fixation
Product CodeMNI
Regulation Number 888.3070
Device Class 2

MDR Year MDR Reports MDR Events
2019 188 188
2020 115 115
2021 274 274
2022 215 215
2023 123 123
2024 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 420 420
Break 200 200
Device-Device Incompatibility 51 51
Migration 49 49
Fracture 46 46
No Apparent Adverse Event 43 43
Device Slipped 36 36
Material Integrity Problem 34 34
Appropriate Term/Code Not Available 34 34
Patient Device Interaction Problem 29 29
Insufficient Information 29 29
Detachment of Device or Device Component 20 20
Compatibility Problem 17 17
Entrapment of Device 16 16
Material Separation 14 14
Material Twisted/Bent 11 11
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Material Deformation 10 10
Mechanical Problem 8 8
Migration or Expulsion of Device 6 6
Material Split, Cut or Torn 6 6
Mechanical Jam 6 6
Unintended Movement 5 5
Material Fragmentation 5 5
Device Dislodged or Dislocated 5 5
Structural Problem 4 4
Patient-Device Incompatibility 4 4
Component or Accessory Incompatibility 3 3
Improper or Incorrect Procedure or Method 3 3
Fitting Problem 3 3
Positioning Problem 3 3
Physical Resistance/Sticking 2 2
Inadequacy of Device Shape and/or Size 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Loose or Intermittent Connection 2 2
Use of Device Problem 2 2
Defective Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Damaged by Another Device 1 1
Difficult to Advance 1 1
Malposition of Device 1 1
Separation Failure 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Misassembled 1 1
Loss of or Failure to Bond 1 1
Crack 1 1
Disconnection 1 1
Solder Joint Fracture 1 1
Inadequate or Insufficient Training 1 1
Noise, Audible 1 1
Misassembly by Users 1 1
Output Problem 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 195 195
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 112 112
Insufficient Information 93 93
Pain 91 91
No Code Available 74 74
Failure of Implant 73 73
Nerve Damage 73 73
Non-union Bone Fracture 72 72
Post Operative Wound Infection 68 68
No Known Impact Or Consequence To Patient 56 56
Unspecified Tissue Injury 52 52
Unspecified Infection 51 51
Osteolysis 49 49
Bone Fracture(s) 37 37
No Consequences Or Impact To Patient 34 34
Hematoma 32 32
Joint Laxity 30 30
Perforation of Vessels 28 28
Cerebrospinal Fluid Leakage 24 24
Intervertebral Disc Compression or Protrusion 24 24
Physical Asymmetry 20 20
Decreased Sensitivity 19 19
Foreign Body In Patient 17 17
No Information 16 16
Vertebral Fracture 16 16
Spinal Cord Injury 13 13
Impaired Healing 12 12
Limited Mobility Of The Implanted Joint 10 10
Neuralgia 10 10
Injury 9 9
Malunion of Bone 9 9
Neck Pain 8 8
Joint Disorder 8 8
Discomfort 7 7
Necrosis 7 7
Implant Pain 7 7
Loss of Range of Motion 6 6
Thromboembolism 6 6
Device Embedded In Tissue or Plaque 6 6
Not Applicable 5 5
Hemorrhage/Bleeding 5 5
Thrombosis/Thrombus 5 5
Spinal Column Injury 4 4
Unspecified Nervous System Problem 4 4
Ambulation Difficulties 3 3
Seroma 3 3
Neurological Deficit/Dysfunction 3 3
Muscular Rigidity 2 2
Wound Dehiscence 2 2
Pulmonary Embolism 2 2
Fall 2 2
Fatigue 2 2
Synovitis 2 2
Stenosis 2 2
Numbness 2 2
Embolism/Embolus 2 2
Deformity/ Disfigurement 2 2
Unspecified Kidney or Urinary Problem 2 2
Unspecified Musculoskeletal problem 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Patient Problem/Medical Problem 1 1
Vascular Dissection 1 1
Speech Disorder 1 1
Balance Problems 1 1
Respiratory Tract Infection 1 1
Complaint, Ill-Defined 1 1
Hypoesthesia 1 1
Cognitive Changes 1 1
No Patient Involvement 1 1
Visual Impairment 1 1
Weakness 1 1
Thrombosis 1 1
Urinary Tract Infection 1 1
Swelling 1 1
Paresis 1 1
Rash 1 1
Scarring 1 1
Sepsis 1 1
Fistula 1 1
Anemia 1 1
Cyst(s) 1 1
Death 1 1
Dysphagia/ Odynophagia 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CTL Medical Corporation II Mar-20-2019
2 Medicrea International II Aug-24-2023
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